Losartan/hydrochlorothiazide Teva-Ratio 50/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Losartan/Hydrochlorothiazide Teva-ratio 50 mg/12.5 mg film-coated tablets

POM

losartan potassium /
hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Losartan/Hydrochlorothiazide Teva-ratio is and what it is used for
2. What you need to know before taking Losartan/Hydrochlorothiazide Teva-ratio
3. How to take Losartan/Hydrochlorothiazide Teva-ratio
4. Possible side effects
5. How to store Losartan/Hydrochlorothiazide Teva-ratio
6. Contents of the pack and other information

1. What Losartán/Hidroclorotiazida Teva-ratio is and what it is used for

Losartán/Hidroclorotiazida Teva-ratio is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to constrict. This results in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, leading to relaxation of blood vessels and a reduction in blood pressure. Hydrochlorothiazide works by making the kidneys excrete more water and salt. This also helps lower blood pressure.

Losartán/hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartán/Hydrochlorothiazide Teva-ratio

Do not take Losartán/Hydrochlorothiazide Teva-ratio

• if you are allergic to losartan, hydrochlorothiazide, or any of the other components of this medicine (listed in section 6)
• if you are allergic to sulfonamide-derived substances (e.g., other thiazides, certain antibiotics such as cotrimoxazole; ask your doctor if you are unsure)
• if you have severe liver impairment
• if you have low levels of potassium or sodium, or high levels of calcium that cannot be corrected with treatment
• if you have gout
• if you are more than 3 months pregnant (It is also preferable to avoid Losartán/Hydrochlorothiazide Teva-ratio during the first months of pregnancy – see section 2: Fertility, pregnancy and lactation)
• if you have severe renal impairment or your kidneys are not producing urine
• if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Losartán/Hydrochlorothiazide Teva-ratio tablets.

If you experience a decrease in vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after taking Losartán/Hydrochlorothiazide Teva-ratio. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you previously had an allergy to penicillin or sulfonamides.

Inform your doctor if you are pregnant (or suspect you may be). Use of Losartán/Hydrochlorothiazide Teva-ratio is not recommended during early pregnancy, and you must not take it after the third month of pregnancy as it may cause serious harm to your baby when used from that point onward (see section “Pregnancy and lactation”).

It is important that you inform your doctor before taking Losartán/Hydrochlorothiazide Teva-ratio:

• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Losartán/Hydrochlorothiazide Teva-ratio, seek medical attention immediately,
• if you have previously had swelling of the face, lips, tongue, or throat,
• if you are taking diuretics (medicines to increase urine production),
• if you are on a low-salt diet,
• if you have had excessive vomiting and/or diarrhea,
• if you have heart failure,
• if you have liver impairment (see “Do not take Losartán/Hydrochlorothiazide Teva-ratio”),
• if you have narrowed arteries supplying the kidneys (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant,
• if you have narrowed arteries (atherosclerosis), angina (chest pain due to poor heart function),
• if you have aortic or mitral valve stenosis (narrowing of heart valves) or hypertrophic cardiomyopathy (a condition causing thickening of the heart muscle),
• if you are diabetic,
• if you have had gout,
• if you have or have had an allergic disorder, asthma, or a condition causing joint pain, skin rashes, and fever (systemic lupus erythematosus),
• if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet,
• if you require anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you have primary hyperaldosteronism (a syndrome associated with excessive aldosterone hormone secretion from the adrenal gland due to gland dysfunction),
• if you are taking any of the following medicines for high blood pressure (hypertension):
• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Losartán/Hydrochlorothiazide Teva-ratio”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartán/Hydrochlorothiazide Teva-ratio”),
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Losartán/Hydrochlorothiazide Teva-ratio.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking losartan/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking losartan/hydrochlorothiazide on your own.

Children and adolescents

There is no experience with the use of Losartán/Hydrochlorothiazide Teva-ratio in children. Therefore, Losartán/Hydrochlorothiazide Teva-ratio should not be given to children.

Other medicines and Losartán/Hydrochlorothiazide Teva-ratio

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, or other medicines that may increase serum potassium (e.g., medicines containing trimethoprim), as combination with Losartán/Hydrochlorothiazide Teva-ratio is not recommended.

Diuretics such as hydrochlorothiazide contained in Losartán/Hydrochlorothiazide Teva-ratio tablets may interact with other medicines. Lithium-containing preparations should not be taken with Losartán/Hydrochlorothiazide Teva-ratio without careful monitoring by your doctor. Special precautionary measures (e.g., blood tests) may be appropriate if you are taking diuretics (water tablets), certain laxatives, glycyrrhizin (found in licorice), medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral antidiabetics or insulin).

It is also important that your doctor knows if you are taking:

• other medicines to lower your blood pressure,
• steroids, medicines for cancer treatment,
• painkillers,
• medicines for fungal infections,
• medicines for arthritis,
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping tablets,
• opioid medicines such as morphine,
• "pressor amines" such as adrenaline or other medicines in the same class,
• oral medicines for diabetes or insulin.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Losartán/Hydrochlorothiazide Teva-ratio” and “Warnings and precautions”).

Please inform your doctor if you are planning to undergo iodine-based contrast imaging while taking Losartán/Hydrochlorothiazide Teva-ratio.

Taking Losartán/Hydrochlorothiazide Teva-ratio with food, drinks, and alcohol

You are advised not to drink alcohol while taking these tablets: alcohol and Losartán/Hydrochlorothiazide Teva-ratio may increase each other's effects.

Excessive dietary salt intake may counteract the effect of Losartán/Hydrochlorothiazide Teva-ratio tablets.

Avoid foods and drinks containing glycyrrhizin (found in licorice), as they may cause abnormal blood electrolyte levels.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide.

Losartán/Hydrochlorothiazide Teva-ratio may be taken with or without food.

Fertility, pregnancy, and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you may be). Your doctor will usually advise you to stop taking Losartán/Hydrochlorothiazide Teva-ratio before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Losartán/Hydrochlorothiazide Teva-ratio is not recommended during early pregnancy, and must not be used from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Use of Losartán/Hydrochlorothiazide Teva-ratio during breastfeeding is not recommended, and your doctor will choose an alternative treatment if you wish to breastfeed.

Elderly patients

Losartán/Hydrochlorothiazide Teva-ratio is equally effective and well tolerated in most elderly and younger patients. Most elderly patients require the same dose as younger patients.

Driving and using machines

When starting treatment with this medicine, do not perform tasks requiring special attention (e.g., driving a car or operating dangerous machinery) until you know how you react to the medicine.

Losartán/Hydrochlorothiazide Teva-ratio contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Losartan/Hydrochlorothiazide Teva-ratio tablets

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Your doctor will decide the appropriate dose of losartan/hydrochlorothiazide based on your condition and whether you are taking other medicines. It is important to keep taking losartan/hydrochlorothiazide as prescribed by your doctor to maintain consistent blood pressure control.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg once daily to control blood pressure over 24 hours. This dose may be increased to 2 film-coated tablets of losartan/hydrochlorothiazide 50 mg/12.5 mg daily or changed to 1 film-coated tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) once daily. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

Administration

The tablets should be swallowed whole with a glass of water.

If you take more Losartan/Hydrochlorothiazide Teva-ratio than you should

In case of overdose, contact your doctor immediately or go directly to the hospital to receive immediate medical attention. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

Inform your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Losartan/Hydrochlorothiazide Teva-ratio

Try to take Losartan/Hydrochlorothiazide Teva-ratio every day as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your regular dosing schedule.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience the following, stop taking Losartán/Hidroclorotiazida Teva tablets immediately and contact your doctor right away or go to the nearest hospital emergency department:

• A severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 in 10,000 patients but less than 1 in 1,000. It may require urgent medical attention or hospitalization.

• Acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion) (very rare (may affect up to 1 in 10,000 people)).

This may require urgent medical attention or hospitalization.

Other possible adverse effects:

Common: may affect up to 1 in 10 people

? Cough, respiratory infection, nasal congestion, sinusitis, sinus disorders.

? Diarrhea, abdominal pain, nausea, indigestion.

? Muscle pain or cramps, leg pain, back pain.

? Insomnia, headache, dizziness.

? Weakness, fatigue, chest pain.

? Elevated potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels.

• Changes in kidney function including renal failure.
• Blood sugar too low (hypoglycemia).

Uncommon: may affect up to 1 in 100 people

• Anemia, red or brown spots on the skin (sometimes especially on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and abdominal pain), bruising, reduced white blood cell count, bleeding disorders, reduced platelet count.
• Loss of appetite, elevated uric acid levels, or manifest gout, elevated blood glucose levels, abnormal blood electrolyte levels.
• Anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment.
• Tingling or similar sensations, limb pain, tremor, dizziness, migraine, fainting.
• Blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow.
• Ringing, buzzing, noise or crackling in the ears, vertigo.
• Low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack, “mini-stroke”), heart attack, palpitations.
• Inflammation of blood vessels, often associated with a skin rash or bruising.
• Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which may cause difficulty breathing), nosebleed, runny nose, congestion.
• Constipation, chronic constipation, gas, stomach disorder, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache.
• Jaundice (yellowing of eyes and skin), inflammation of the pancreas.
• Hives, itching, skin inflammation, rash, redness of the skin, photosensitivity, dry skin, flushing, sweating, hair loss.
• Pain in arms, shoulders, hips, knee or other joints, joint swelling, stiffness, muscle weakness.
• Frequent urination, including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in urine.
• Decreased sexual appetite, impotence.
• Facial swelling, localized swelling (edema), fever.

Rare: may affect up to 1 in 1,000 people

? Hepatitis (inflammation of the liver), abnormal liver function tests.

• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known: frequency cannot be estimated from available data

• Flu-like symptoms.
• Muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis).
• Low sodium levels in blood (hyponatremia).
• Generally feeling unwell (malaise).
• Altered taste (dysgeusia).
• Skin rashes and skin lesions (cutaneous lupus erythematosus).
• Skin and lip cancer (non-melanoma skin cancer).
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma].

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan/Hydrochlorothiazide Teva-ratio

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Losartan/Hydrochlorothiazide Teva-ratio tablets

• The active substances are losartan potassium and hydrochlorothiazide. Each tablet contains
50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460a), pregelatinized starch (from corn), magnesium stearate (E572).

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b), yellow iron oxide (E172).

Appearance of Losartan/Hydrochlorothiazide Teva-ratio and contents of the pack

• Losartan/Hydrochlorothiazide Teva-ratio 50 mg/12.5 mg film-coated tablets are yellow, oval, biconvex tablets, marked with “5” and “0” on one side and a scored line on both sides.

The tablet can be divided into equal doses.

The 50 mg/12.5 mg tablets are available in pack sizes of 1, 14, 20, 28, 30, 56, 60, 84, 90, 98, and 100 tablets, calendar packs of 28 tablets, and hospital packs of 50x1 and 280 (10x28) tablets.

HDPE bottles with screw cap and tamper-evident closure: 28, 100, 250 tablets, and clinical pack of 500 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabel Segura 11. Edificio Albatros B, 1st floor.
28108 Alcobendas. Madrid.
Spain

Manufacturer:

Pharmachemie B.V.
P.O. Box 552
2003 RN Haarlem
The Netherlands

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13, H-4042 Debrecen
Hungary

Teva Czech Industries s.r.o.
Ostravskà 29, 747 70 Opava-Komarov,
Czech Republic

Teva Pharma, S.L.U
C/ C, nº 4, Polígono Industrial Malpica,
50016 Zaragoza
Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:

Date of the last revision of this leaflet: January 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning the QR code included on the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70595/P_70595.html